This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels.

Clinical evaluation will take place at weekly intervals until wound closure and then monthly for a period of no less than 12 months.

Once the safety and dose-response analysis in Specific Aim 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Specific Aim 1 will establish the maximum safe dose that will be used in this Phase II efficacy tria

Allogeneic (MSC's) Application to the Burn Wounds. The first group of 5 will be started on the lowest dose. If there are no adverse reactions, the second group of 5 will receive a higher dose. This will be repeated for the third and fourth groups with each receiving a higher dose

Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm.

Second dose level 5 X 10³ Allogeneic MSCs cells/square cm.

Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm.

Fourth dose level 2 X 10⁴ Allogeneic MSCs cells/square cm.

Up to 2 administrations of cells will be allowed per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart.

Biological: Allogeneic (MSC's) Application to the Burn Wounds

Allogeneic (MSC's) Application to the Burn Wounds. The first group of 5 will be started on the lowest dose. If there are no adverse reactions, the second group of 5 will receive a higher dose. This will be repeated for the third and fourth groups with each receiving a higher dose

Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm.

Second dose level 5 X 10³ Allogeneic MSCs cells/square cm.

Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm.

Fourth dose level 2 X 10⁴ Allogeneic MSCs cells/square cm.

Up to 2 administrations of cells will be allowed per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart.

No anomalies on the CBC and differential suggestive of a hematopoietic disorder

Creatinine ≤ 1.5 mg/dL

ALT ≤ 112 IU/L

AST ≤ 100 IU/L

Bilirubin < 1.5 mg/dL

No diabetes

Systolic blood pressure ≤ 170

Diastolic blood pressure ≤ 90

No history of autoimmune disorders

Recipients:

Inclusion Criteria:

Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds

Injury within the prior 7 days

Subjects must understand and give written informed consent.

Subjects must agree to have biopsies performed as per protocol

Subjects must be accessible for weekly wound treatment and assessment visits

Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, birth control pills, depoprogesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide create or gel, or an intrauterine device (IUD).

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104713